Morristown, N.J., and Lexington, MA, February 16, 2016 – Capsugel and Pulmatrix, Inc. (“Pulmatrix”) (NASDAQ: PULM) have formed a collaboration to develop novel inhaled therapeutics to treat serious pulmonary diseases. The agreement provides Capsugel exclusive rights to manufacture clinical trial and commercial batches of iSPERSE™-based inhaled therapeutic candidates being developed by Pulmatrix and its potential development partners. Capsugel will combine its spray drying process development, scale-up expertise and commercial manufacturing capabilities at its Bend Research facility in Bend, Ore. with Pulmatrix’s iSPERSE (inhaled small particles easily respirable and emitted) technology.
“This strategic partnership with Pulmatrix puts our companies at the forefront of bringing unique inhalation products to the market to deliver better patient outcomes,” said Dan Dobry, Head of Alliance Strategy at Bend Research, a division of Capsugel Dosage Form Solutions. “We look forward to working with Pulmatrix to help advance its pipeline of proprietary and partnered products utilizing our spray dry technology and infrastructure, and to jointly explore opportunities to collaborate with the broader pharmaceutical industry to develop next-generation inhalation therapies.”
Pulmatrix’s iSPERSE dry powder technology is a small, dense and dispersible engineered particle technology that enables pulmonary delivery of drugs with high delivery efficiency, dose reproducibility and flow-rate independence. Several products leveraging the iSPERSE platform are in development, including a lead clinical stage bronchodilator (PUR0200) for chronic obstructive pulmonary disease (COPD), an inhaled anti-fungal (PUR1900) for cystic fibrosis (CF) and a pipeline of products for use in the treatment of rare pulmonary diseases, CF and idiopathic pulmonary fibrosis.
“This collaboration provides us with access to Capsugel’s spray dry technology, scale-up capabilities, and state-of-the-art equipment to support our growing pipeline of internal and partnered development programs,” said Pulmatrix CEO Robert Clarke, Ph.D.
Pulmatrix’s chief scientific officer, David Hava, Ph.D., added: “In the near term, Capsugel will fulfill manufacturing needs for our planned clinical trial activities in cystic fibrosis and, longer term, will enable us to manufacture iSPERSE-based products at commercial scale. With this partnership, we can achieve these goals cost-effectively and without the risk or required capital to build and maintain these essential capabilities.”
Capsugel and Pulmatrix have played leadership roles in the development of spray drying as an enabling technology to address the limitations of conventional lactose blending dry powder inhaler (DPI) and metered dose inhaler (MDI) technologies. Spray drying technology provides fewer formulation dependencies, the ability to deliver either crystalline or amorphous drugs, and tighter particle size distribution than that provided by lactose blend technology. This engineered particle approach and expertise applied to the iSPERSE technology translates into significantly improved delivery efficiency, flow-rate independence and drug dosing for patients. The proprietary iSPERSE technology is backed by a strong intellectual property estate extending into the 2030s.
Capsugel continues to make significant investments to maintain and build its premier spray drying capabilities and capacity. In June 2015, Capsugel completed a two-year, more than $25 million investment to expand Bend Research’s spray drying commercial manufacturing facility, providing the company with the largest integrated pharmaceutical spray drying technology capability in North America. Capsugel is also investing to expand its late-stage inhalation offering to include full cGMP analytical services and large-scale encapsulation for DPI applications.
Capsugel is a global leader in delivering high-quality, innovative dosage forms and solutions to its customers in the health care industry. The company’s Hard Capsule business offers customers the broadest portfolio of gelatin, vegetarian, and other specialized capsule technologies. Capsugel’s Dosage Form Solutions business utilizes an array of proprietary technologies and specialized manufacturing capabilities to solve customers’ most pressing product development challenges, including bioavailability enhancement, modified release, abuse deterrence, biotherapeutic processing, and inhalation formulation. The company's fast-to-clinic program streamlines product development from pre-formulation through clinical and commercial supply for finished dosage forms. Headquartered in Morristown, N.J., Capsugel serves more than 4,000 customers in more than 100 countries. For additional information, visit www.capsugel.com.
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE technology. Pulmatrix’s proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF), as well as PUR1500, an inhaled product for the treatment of idiopathic pulmonary fibrosis. In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD).
Pulmatrix's product candidates are based on iSPERSE, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes. For more information, visit www.pulmatrix.com.
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Pulmatrix cautions that such statements involve risks and uncertainties that may materially affect Pulmatrix’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Pulmatrix’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Pulmatrix’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to Pulmatrix, is set forth in Pulmatrix’s most recent quarterly report on Form 10-Q filed by Pulmatrix with the Securities and Exchange Commission. Pulmatrix disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.